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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal BDK-0016228-7/1/1

Manufacturer FEI3007070719
Manufacturer NameSuave Y Facil Sa De Cv  
Manufacturer Address line 1Escape No. 10fraccionamiento  
Manufacturer Address line 2  
Manufacturer's CityNeucalpan De Juarez  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53ED06  
Importer's Product DescriptionHAIR SHAMPOO  
Refusal Date30-Aug-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BDK-0016228-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.